UAB - Center for Clinical and Translational Science

A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease

Purpose

The purpose of this study is to assess the efficacy and safety of K-161 ophthalmic solution for the treatment of moderate to severe dry eye disease.

Condition

Dry Eye Disease

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Be at least 18 years of age at the time of Informed Consent - Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptom - Meet all other inclusion criteria outlined in the clinical study protocol

Exclusion Criteria

Have any clinically significant ocular condition - Have a history of corneal refractive surgery and/or any other ocular surgical procedure within 12 months - Meet any other exclusion criteria outlined in the clinical study protocol

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental K-161	K-161 Ophthalmic Solution	Drug: K-161 K-161 Ophthalmic Solution
Placebo Comparator Placebo	Vehicle Solution	Drug: Placebo Vehicle Solution

More Details

Status: Active, not recruiting
Sponsor: Kowa Research Institute, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.